Optical imaging device

Information

  • Patent Grant
  • 11782257
  • Patent Number
    11,782,257
  • Date Filed
    Friday, July 22, 2022
    a year ago
  • Date Issued
    Tuesday, October 10, 2023
    7 months ago
  • Inventors
  • Examiners
    • Wong; Tina M
    Agents
    • Farber LLC
Abstract
Systems and methods are providing for endoscopically visualizing tissue within a patient. In one aspect, an endoscope comprises an elongate shaft having a distal end and a proximal end and a visualization section at the distal end of the shaft. The visualization section includes a proximal surface and an outer surface spaced apart from the proximal surface. At least one of the proximal surface or the outer surface of the visualization section has an average surface roughness less than about 50 nanometers RMS. The endoscope allows improved remote visualization while not interfering with the autofocus feature of a video capture system and not causing increased light reflectance and glare due to improved surface finish.
Description
FIELD

Systems and methods are provided for improved optical imaging of target areas by an optical imaging visualization device, such as an endoscope, laparoscope, arthroscope, ophthalmoscope, borescope, or other remote imaging visualization technology.


BACKGROUND

Remote optical visualization devices such as endoscopes and other optical imaging visualization devices illuminate surfaces and other objects a distance from the user of the visualization device, allowing a user to perform a diagnosis or procedure using images and signals generated and transmitted a distance from the observed object. This can include, for example, viewing tissue inside a body cavity or a lumen, inspecting a hydraulic line in an aircraft, inspecting an oil pipeline for leaks, or inspecting a sewer line for leaks and/or blockages. Remote optical visualization devices transmit these images to the viewer in a variety of ways, including, among others, through the use of (i) relay lenses between the objective lens at the distal end of the scope and an eyepiece, (ii) fiber optics, and (iii) charge coupled devices (CCD) and complementary metal oxide semiconductor (CMOS) sensors. Frequently, a video capture system is connected to the optical visualization device to display a video image on a display monitor that can be viewed by a user during use of the optical visualization device, including the ability to adjust the focus of the display through manual adjustments or autofocus capability in a video processor system used with the optical imaging device. To achieve video capture with a video processor system, an objective lens of an optical visualization device focuses light reflected from a target being observed on an image sensor. The image sensor outputs signals based on the detected reflected light. The signals from the image sensor are output to a signal processor, which typically includes imaging software that controls an autofocus feature connected to the objective lens to adjust the in-focus object plane position. A control signal generated by the signal processor activates an autofocus operation to automatically bring the target being observed into focus.


Optical couplers positioned over the objective image capturing element of an optical visualization device allow improved remote observation in areas of the body where visibility has been obstructed by blood, stomach content, bowel content, or other opaque fluids and/or solid particulate matter. Optical couplers also allow improved remote observation in non-medical applications where visibility has been obstructed by fluids and/or solid particulate matter. However, imperfections on the surface of the optical coupler may inhibit the visualization of the optical visualization device, including confusing the signal processor of an optical visualization device using a video capture system, causing the autofocus feature to focus the objective lens on a surface of the optical coupler, rather than on the intended target to be observed. Further, when an optical coupler is used with visualization systems that do not use image capture software, visualization may be hindered when the light from the visualization system passes through imperfections on the distal surface of the optical coupler resulting in increased light reflection and increased glare due to these imperfections. This may occur when light proceeds through the optical coupler and when light returns back through the optical coupler to the scope camera.


It would be advantageous to provide an endoscope that allows improved remote visualization while not interfering with the autofocus feature of a video capture system and not causing increased light reflectance and glare due to improved surface finish.


SUMMARY

Endoscopes are provided with one or more distal surfaces having a defined degree of roughness. In embodiments, a surface of the endoscope has a Root Mean Square (RMS) Roughness below about 20 nanometers, in embodiments from about 5 nanometers to about 18 nanometers. In embodiments, the surface roughness of the endoscope surface is below about 0.5 nanometers, in embodiments from about 0.1 nanometers to about 0.4 nanometers. In embodiments, a surface of the endoscope has a Root Mean Square (RMS) Roughness below about 20 nanometers with spatial frequencies between 1×10−1 mm−1 to 1×103 mm−1, in embodiments Y from about 5 nanometers to about 18 nanometers for a similar spatial frequency range.


The “surface roughness of the endoscope surface is below about 0.5 nanometers” means that one of the center-line mean roughness (Ra), the ten-point height irregularities (Rz), and the maximum height roughness (Rmax) is less than 0.5 nanometers, ±0.05 nanometers. In embodiments, a surface of the endoscope has a center-line mean roughness (Ra) of no more than about 0.5 nanometers, in embodiments, from about 0.1 nanometers to about 0.4 nanometers. In embodiments, a surface of the endoscope has a ten-point height irregularities (Rz) of no more than about 0.5 nanometers, in embodiments, from about 0.1 nanometers to about 0.4 nanometers. In embodiments, a surface of the endoscope has a maximum height roughness (Rmax) of no more than about 0.5 nanometers, in embodiments, from about 0.1 nanometers to about 0.4 nanometers. In embodiments, a surface of the endoscope has an average defect density of no more than about 100 defects per 10 μm2, in embodiments from about 10 defects per 10 μm2 to about 75 defects per 10 μm2. In embodiments, the distal surface of the endoscope has a defined degree of roughness. In embodiments, the surface of the endoscope closest to the objective lens has a defined degree of roughness.





BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:



FIG. 1 is a side view of a first embodiment of an optical coupler;



FIG. 2 is a cross-sectional view of the optical coupler of FIG. 1 taken along line 2-2 of FIG. 1; and



FIG. 3 is a cross-sectional view of the optical coupler of FIGS. 1 and 2 taken along line 3-3 of FIG. 2, the optical coupler being attached to an endoscope.





The figures depict specific embodiments of the present disclosure for purposes of illustration only. One skilled in the art will readily recognize from the following discussion that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles of the present disclosure described herein.


DETAILED DESCRIPTION

The present endoscopes provide for improved optical imaging of surfaces covered with opaque fluids, semisolid materials or particulate matter, without interfering with the autofocus feature and other image capture and transmission elements of the optical imaging visualization device and its related system elements. These advantages are provided by ensuring that one or more surface(s) of the endoscope in the optical path has a defined degree of roughness, as described in more detail below.


The devices and methods described herein can be used in various applications. With Natural Orifice Translumenal Endoscopic Surgery (NOTES), the coupler enables procedures to continue when unexpected bleeding or other fluids such as bile or stomach contents obstruct the view. Also, the coupler can create or increase working space by pushing organs out of the field of view. With a laryngoscope in trauma and emergency situations, the coupler would push blood, foreign objects, or food away to increase visibility to allow visualizing of the trachea. When taking biopsies is required, the coupler isolates the intended biopsy target, the tumor or area to be biopsied from surrounding tissue. Close focusing and contact with the tissue with the aid of the coupler can improve reliability by allow multiple biopsies to taken in exact locations defining borders of the tumor, and minimize tumor cells from entering the blood stream or lymph channels. A cautery probe or electrode can be used simultaneously or in conjunction with the biopsy forceps, minimizing bleeding and length of procedure.


The coupler can be used in various endoscopic intra-cardiac procedures such as: (1) myocardial biopsy (for transplant monitoring or tumor sampling); (2) valve repair or reconstruction; (3) patent foramen oval (PFO) closure; (4) ventricle septal defect (VSD) closure; (5) pacing wire placement or removal; (6) stem cell injection; (7) coronary sinus cannulations (8) and maze procedure. In cryoablation, a specialized composite coupler could be made that has warming channels to warm the external surface of the coupler to protect surrounding tissue from freezing. In radiofrequency ablation, insulating and isolating properties of the coupler would concentrate power, protecting surrounding tissue.


The coupler can be used in various vascular procedures. The coupler can be used to guide proper placement of covered stents in dissected aortas, or visualize an intra-vascular laser. The coupler could be used to inspect the suture line of a large or small vessel anastomosis to evaluate the quality of the suturing and or determine the location of any bleeding.


In certain surgical or trauma situations there is severe arterial bleeding from a wound or vessel. Often the first action taken is to compress a finger or sponge on the area of bleeding. After time passes the finger or sponge is removed. If the bleeding continues either more compression or other actions are taken such as blind clamping, suctioning the blood away and then clamping and suturing, or homeostatic materials are applied. Blood loss can be substantial. An embodiment mounted at the end of a finger shaped wand can be compressed over a bleeding site, both clearing the field of blood and creating a view to locate the point of bleeding. Since the coupler is clear, soft and biocompatible, a suture or staple can be passed though the coupler to repair the bleeding site.


The working channels within the coupler or parallel to the coupler allow surgical instruments, probes, biopsy needles, needles, sutures etc. to be passed to the area being viewed. Since the coupler is flexible, the channels can move within or around the coupler without compromising its function. One enabling property of the coupler is its soft flexible shape that conforms to the tissue or object being viewed. This characteristic reduces damage to delicate tissues or structures.


Another advantage of the coupler is that only the specific area being viewed through the coupler attached to the endoscope requires illumination and therefore, the targeted view requires less light to be supplied by the endoscope lighting system. Because the number of light fibers required for illumination is less, endoscopes can be smaller or less expensive to manufacture. Also, since it is only necessary to illuminate the area of the coupler at its outer boundary, endoscopes of smaller diameter would be required to view a targeted area.


The coupler can be a semi-solid gel, which is transparent and flexible, that attaches to a wide variety of endoscopes. For minimally invasive procedures, the smallest possible scope is used. The optimal shape and size of the coupler can be determined by the field of view of the endoscope, or conversely an endoscope can be chosen that will match the size and shape of the coupler. The shape of the coupler can be manufactured with a preformed shape matched to the contour of the object that will be examined, for example an endoscope coupler could be made in the shape of the blood pool at the apex of the heart. This coupler can be used in conjunction with a 2 mm angioscope maneuvered into the apex of the heart and displace the blood to visualize the inside wall of the ventricle of the beating heart.


The coupler can be attached to the endoscope with a clear adhesive material. The coupler can be attached as a screw on auxiliary lens or filter allowing different couplers with different purposes or functions to be utilized with the same scope. The coupler can be attached and held in place with suction. The coupler can be attached by sewing on with sutures. The coupler can be attached with wire, nylon or other braid material. The coupler can be attached to endoscopes with mesh or pliable membranes. When using a mesh net to attach the coupler to the endoscope, gel strength and viscosity must be high enough to prohibit gel flow through holes in the outer layer of mesh.


A coupler can be compressed in a tube fixed to the end of the scope. A coupler attached to the endoscope can be compressed in a retractable sheath. Embodiments of the coupler can have one, two or more working channels that align with the endoscope's working lumens. Other versions of the coupler allow for additional internal channels or along the edges of the device for use in more complex procedures, such as suturing.


The coupler can be used in any minimally invasive procedure. Biopsies in the body, for example, could be taken under direct view, reducing the need for CO2 inflation. The coupler allows exact placement of needles and medical devices in situations where active bleeding or other bodily fluids impede visibility. The coupler can be held with pressure over an active bleeding site to stop bleeding until the suturing process, stapling, clamping or medical device placement is complete.


Turning now to FIGS. 1-3, an embodiment of an optical coupler 10 is shown. The optical coupler 10 includes a visualization section 12 at a distal end 13 of optical coupler 10. Visualization section 12 has a generally slightly curved, convex outer surface 14 that extends from a first outer side boundary 15 to a second opposite outer side boundary 16 of optical coupler 10, and a proximal surface 18. In other embodiments, the visualization section may be non-curved and other embodiments may be concave. Outer surface 14 may be spaced apart from proximal surface 18 of optical coupler 10 by a length D (see FIG. 1). In some embodiments, a hollow instrument channel 19 extends from proximal surface 18 toward outer surface 14. Instrument channel 19 may not extend all the way through visualization section 12 to the outer surface 14. In such a case, a barrier section 20 of material is provided between a distal end 21 of instrument channel 19 and outer surface 14 of optical coupler 10.


Optical coupler 10 also includes an attachment section 22 connected to and extending away from visualization section 12. Attachment section 22 is at the proximal end 23 of optical coupler 10. In the embodiment shm.vn, attachment section 22 is in the fom1 of a cylindrical wall 24. Proximal surface 18 and cylindrical wall 24 of optical coupler 10 define a cylindrical opening 25 of optical coupler 10 within cylindrical wall 24. In other embodiments, the optical coupler may be attached in other manners, including using a gel or glue.


Referring to FIG. 3, optical coupler 10 can be mounted on an endoscope 30. Endoscope 30 has a distal end 31 that is inserted in cylindrical opening 25 of optical coupler 10. Endoscope 30 has a sheath 32 with an outer surface 33 that snugly engages cylindrical wall 24 of optical coupler 10. An end surface 34 of endoscope 30 sealingly engages proximal surface 18 of optical coupler 10. Endoscope 30 includes a first lumen 35, a second lumen 36 and a third lumen 37 that extend from end surface 34 of endoscope 30 to a proximal end (not shown) of endoscope 30. A light guide 39 positioned in the first lumen 35 transmits light toward a surface area at or beyond outer surface 14 of optical coupler 10. An objective lens 40 is optically connected to a distal end of image carrying fiber 42. Objective lens 40 receives light reflected from the surface area being viewed and image carrying fiber 42 transmits the reflected light to a video capture system (not shown) at a proximal end (not shown) of image carrying fiber 42. Objective lens 40 and image carrying fiber 42 are located in second lumen 36. Third lumen 37 aligns with hollow instrument channel 19 of optical coupler 10 when optical coupler 10 is mounted on endoscope 30. Optical coupler 10 can also include a Light Emitting Diode (LED) 11 near outer surface 14 of the coupler to provide illumination prior to optical coupler 10 contacting any fluids, tissue, or structure. LED 11 may be provided power via a wire (not shown) in endoscope 30 or from an external source. Additional details regarding the construction and alternative embodiments of suitable optical couplers can be found in Published U.S. Patent Application No. US2012/0209074A1, the entire content of which is incorporated herein by this reference.


Outer surface 14 and proximal surface 18 of optical coupler 10 lie within the optical path of objective lens 40. In accordance with the present disclosure, at least one of outer surface 14 or proximal surface 18 of optical coupler 10 is provided with a defined degree of roughness. The degree of roughness is the aggregate of any textural constituent elements present on the lens. The size of the textural constituent element is not particularly limited provided the overall degree of roughness does not interfere with the visualization of the image transmitted by the image capture system associated with the endoscope onto which the optical coupler has been mounted.


In embodiments, the outer surface of the coupler transmits both the light used for illumination and the returning light used for imaging simultaneously. This common-path illumination and imaging lens allows for uniform illumination of an object near or at the focal region of the optical imaging visualization device. However because of this, any surface defects may cause light to be refracted or reflected back toward the camera and cause glare or reduced contrast. Also, even a very smooth transmitting surface will reflect a small percentage of light due to Fresnel reflections; therefore, the figure and location of the lens surface must be controlled such that light emitted from the illumination source will not reflect as such angles as to cause unwanted glare along with the surface finish with a defined degree of roughness.


In embodiments, the length and the width of any given textural constituent element can both be 10 μm or less. In embodiments, the length of the textural constituent element (size of the textural constituent element in the longer direction) is 3 μm or less and the width (size of the textural constituent element in the shorter direction) 500 nm or less. In other embodiments, the length and the width of the textural constituent element are preferably in the range of 3 μm to 50 nm. In embodiments, the depth of the textural constituent element may be 15 nm to 200 nm.


In embodiments where outer surface 14 or proximal surface 18 of optical coupler 10 includes depressions, the depressions have an average diameter less than 100 nanometers, in embodiments, from about 15 to about 50 nanometers. The depressions may have an average depth less than about 100 nanometers, in embodiments from about 4 nanometers to about 50. The depressions may have a density or an average density, meaning the number of depressions per 100 square micrometers of surface or the average number of depressions per 100 square micrometers of surface, of less than about 100 depressions per 100 square micrometers of surface, in embodiments from about 15 to about 50 depressions per 100 square micrometers of surface.


In embodiments, a surface of the optical coupler has a Root Mean Square (RMS) Roughness below about 200 Angstroms; in embodiments, from about 50 Angstroms to about 180 Angstroms. In embodiments, the surface roughness of the optical coupler surface is below about 0.5 nanometers, in embodiments from about 0.1 nanometers to about 0.4 nanometers. The “surface roughness of the optical coupler surface is below about 0.5 nanometers” means that one of the center-line mean roughness (Ra), the ten-point height irregularities (Rz), and the maximum height roughness (Rmax) is less than 0.5 nanometers, ±0.05 nanometers. In embodiments, a surface of the optical coupler has a center-line mean roughness (Ra) of no more than about 0.5 nanometers, in embodiments, from about 0.1 nanometers to about 0.4 nanometers. Tn embodiments, a surface of the optical coupler has a ten-point height irregularities (Rx) of no more than about 0.5 nanometers, in embodiments, from about 0.1 nanometers to about 0.4 nanometers. In embodiments, a surface of the optical coupler has a maximum height roughness (Rmax) of no more than about 0.5 nanometers, in embodiments, from about 0.1 nanometers to about 0.4 nanometers. In embodiments, a surface of the optical coupler has an average defect density of no more than about 100 defects per 10 μm2, in embodiments from about 10 defects per 10 μm2 to about 75 defects per 10 μm2. In embodiments, outer surface 14 of optical coupler 10 has a defined degree of roughness. In embodiments, proximal surface 18 of optical coupler 10 (i.e., the surface closest to the objective lens of the endoscope) has a defined degree of roughness.


The degree of roughness can be determined by using any technique within the purview of those skilled in the art, such as, for example, a laser surface analyzer or a stylus surface profiler, but it can also be determined, simply by direct observation of the surface and cross section under SEM.


A defined degree of roughness is provided on a surface of the optical coupler using techniques within the purview of those skilled in the art. The specific method chosen will depend on a number of factors including the material from which the optical coupler is made.


Optical coupler 10 can be formed from a variety of materials exhibiting transparency or translucency and biocompatibility in medical applications. In embodiments, an optical coupler for non-medical applications can be formed from a variety of materials exhibiting transparency or translucency.


In embodiments, a rigid material, e.g., a resin material such as cycloolefin polymer or polycarbonate, is used to form the optical coupler. When rigid materials are used, they are typically molded and then one or more surface is polished to impart a defined degree of roughness. Polishing techniques are within the purview of those skilled in the art and include, for example, chemical-mechanical polishing, mechanical polishing, CMP processes, reactive ion etching (e.g., with a substantially chemically etching component), physical etching, and wet etching.


In embodiments, a flexible material is used to form the optical coupler. Flexible materials are typically difficult to polish. Accordingly, where flexible materials are used, a defined degree of roughness is provided on the surface of a mold and imparted to the optical coupler when it is molded.


In embodiments, the mold is prepared by any technique within the purview of those skilled in the art, such as for example, the use of a series of micropolish compounds to prepare and refine the finish of the mold to the point where the mold can produce an optical coupler with the desired surface finish on the optical coupler, and, alternatively, creating the mold using single-point diamond turning to cut the surface of the mold with a level of refined surface that the mold produces an optical coupler with the desired surface finish on the optical coupler.


In embodiments, optical coupler 10 is molded from a material selected from glass, silicone gels, silicone elastomers, epoxies, polyurethanes, polycarbonates, acrylics, other elastic materials, and mixtures thereof. The silicone gels can be lightly cross-linked polysiloxane (e.g., polydimethylsiloxane) fluids, where the cross-link is introduced through a multifunctional silane. The silicone elastomers can be cross-linked fluids whose three-dimensional structure is much more intricate than a gel as there is very little free fluid in the matrix. In other embodiments, optical coupler 10 is made from a material selected from hydrogels, such as polyvinyl alcohol, poly(hydroxyethyl methacrylate), polyethylene glycol, poly(methacrylic acid), and mixtures thereof. The material for optical coupler 10 may also be selected from albumin based gels, mineral oil based gels, polyisoprene, or polybutadiene. In embodiments, the material is viscoelastic.


In embodiments, the optical coupler is a clear gel attached to the outer distal portion of any optical imaging or image capturing device, such as an endoscope or camera lens. When pressed in contact with the surface of an area to be viewed, the gel creates an offset that allows clear visualization by mechanically displacing the opaque liquid or soft semisolids.


The material used to form the optical coupler can be comprised of two or more compounds, for example an opaque compound attaches and holds two visualization portions of a coupler in position, the first visualization portion is an inner clear semi rigid compound shaped to match the field of view and minimum depth field of the imaging system, and the second portion is attached to the outer boundary of the first visualization portion and is composed of very soft gel providing additional area of fluid displacement for maneuvering and positioning instruments under direct vision. In embodiments, the two or more compounds each can be of materials that exhibit transparency or translucency. Methods described in U.S. Pat. Nos. 7,235,592 and 7,205,339 can be utilized to produce a coupler with portions or areas of the gel with different physical properties.


Referring back to FIGS. 1-3, in the optical coupler 10, the material is optically clear such that the light guide 39 can transmit light through the optical coupler 10 toward a surface area at or beyond the outer surface 14 of the optical coupler 10 and such that the optical coupler 10 is capable of transmitting an optical image of the surface area being viewed back to the lens 40. In embodiments, the material has a degree of light transmittance greater than 80% based on test standard ASTM D-1003 (Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics). In other embodiments, the material has a degree of light transmittance greater than 98% based on test standard ASTM D-1003. In embodiments, the material has an optical absorption of less than 0.1%) in the visible light range, and, in embodiments, an optical absorption of less than 0.01%; in the visible light range. In embodiments, the material has an index of refraction of about 1.3 to about 2.2, and in embodiments, the index of refraction of the material matches the index of refraction of the light guide 39, or is as low as possible.


The optical coupler 10 may also be coated. Coating may reduce the amount of adherence properties and/or reduce unwanted light reflections, and/or change and enhance the optical coupler by adding hydrophobic or hydrophilic properties. Suitable coatings that may be used on the optical coupler include, but are not limited to, polymers based on p-xylylene, such as for example, polymers that are commercially available under the trade name Parylene C, which is an optically clear biocompatible polymer having abrasion resistant and hydrophobic or hydrophilic properties.


EXAMPLES

The following Examples have been presented in order to further illustrate the devices and methods described herein and are not intended to limit the invention(s) in any way.


Example 1

A series of optical couplers in a shape similar to that of FTG. 3 was molded from Nusil MED-6033 an optical grade liquid silicone elastomer available from Nusil Technologies, Carpinteria, California. This silicone has an index of refraction of 1.41, and a durometer of about 45 on the Shore 00 scale. The surface of the mold forming the outer surface of the optical coupler was manufactured using a micropolishing methodology to impart a surface finish better than the Society of Plastic Industry (SP1) Al finish on to the mold. The surface finish of the mold and the resulting lenses were measured using a Zygo interferometer to determine the surface finish on the distal surface of the optical coupler.


These optical couplers were then placed on a number of scopes, including an Olympus CF-Q160A/L colonoscope, a 10 mm rigid laparoscope and a Pentax EG-2990 gastroscope. The visual performance of these optical couplers was observed to determine the impact of surface finish on the visual performance of these scopes without an optical coupler and with an optical coupler. and the following was noted: The lenses measured with this approach had the following attributes:














TABLE A








Surface
Surface
Interfere



Optical
Roughness
Roughness
With Image



Coupler
(RMS)
(Ra)
(Yes/No)









1
21.1646 nm
10.2766 nm
Yes



2
40.3157 nm
18.0538 nm
Yes



3
32.9431 nm
13.8726 nm
Yes



4
25.1743 nm
11.4089 nm
Yes



5
12.0249 nm
 8.5337 nm
No



6
12.7432 nm
10.1406 nm
No










To further assess the variations in the surface finish of the optical couplers, assessments were performed by placing the couplers on the scopes mentioned above and moving various targets in close and away from the endoscope, at specific distances ranging from 3 mm out to several centimeters to assess how changes in light and object distance impact optical performance, relative to surface finish. In addition, the optical couplers were tested at these various distances in situations involving fluid and debris to determine the impact of various levels of surface finish and various distances and environments on visual performance. The performance of these optical couplers was compared to the performance of a scope without the optical coupler to determine an acceptable surface finish that did not interfere with the capture of the visual image through the optical coupler.


As can be seen from the data in Table A, a surface roughness of less than 12.7432 nm RMS did not interfere with the video capture and autofocus software, while surface roughness in excess of this level of surface roughness confused the software, and caused the image of target tissue displayed by the endoscope to be intemlittently out of focus. Further, when lenses were tested on scopes without imaging software, the glare and reflection was unacceptably high, inhibiting performance, at the surface roughness greater than 12.7432 nm RMS.


Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure. As well, one skilled in the art will appreciate further features and advantages of the present disclosure based on the above-described embodiments. Accordingly, the present disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.


It should be understood that the foregoing description is only illustrative of the present disclosure. Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. For example, the coupler may be used in non-medical applications wherein the coupler is attached to the distal end of a borescope or attached to micro, conventional, or robotic video cameras, inspection scopes, or still cameras, thereby allowing viewing and/or making repairs inside pipes, holding tanks, containers, etc. without the need to empty the pipes or containers of static or moving opaque fluid, such as petroleum products, sewerage, food products, paint, etc. In non-medical, industrial applications, the coupler can be formed from materials that resist acid, alkalinity, high heat, or viscosity of fluid being displaced by the coupler and may be reusable. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variances. The embodiments described with reference to the attached drawing figures are presented only to demonstrate certain examples of the disclosure. Other elements, steps, methods and techniques that are insubstantially different from those described above and/or in the appended claims are also intended to be within the scope of the disclosure.

Claims
  • 1. An endoscope comprising: an elongate shaft having a distal end and a proximal end;a visualization section at the distal end of the shaft the visualization section including a proximal surface and an outer surface spaced apart from the proximal surface; andwherein at least one of the proximal surface or the outer surface of the visualization section has an average surface roughness less than about 50 nanometers RMS.
  • 2. The endoscope of claim 1, further comprising an attachment section connected to and extending away from the visualization section, the attachment section being dimensioned to be coupled to the distal end of the shaft.
  • 3. The endoscope of claim 2, wherein the attachment section is removably, coupled to the shaft.
  • 4. The endoscope of claim 1, wherein at least one of the proximal surface or the outer surface of the visualization section has a plurality of depressions with an average diameter less than about 150 nanometers.
  • 5. The endoscope of claim 1, further comprising a light guide within the shaft, wherein the light guide has a first index of refraction and the visualization section has a second index of refraction, wherein the first and second indexes of refraction are substantially the same.
  • 6. The endoscope of claim 1, wherein at least one of the proximal surface or the outer surface of the visualization section has an average surface roughness of from about 5 to about 30 nanometers RMS.
  • 7. The endoscope of claim 1, wherein the visualization section comprises a material having an index of refraction of about 1.3 to about 2.2.
  • 8. The endoscope of claim 1, further comprising an instrument channel extending through the visualization section.
  • 9. The endoscope of claim 8, wherein the instrument channel has a proximal end for coupling to a working channel of the endoscope and a distal end at the outer surface of the visualization section.
  • 10. The endoscope of claim 1, wherein the visualization section comprises a substantially transparent material for transmitting light therethrough.
  • 11. The endoscope of claim 1 further comprising a light emitting element near, or on, the outer surface.
  • 12. An endoscope comprising: an elongate shaft having a proximal end and a distal end;a visualization section at the distal end of the shaft, the visualization section including a proximal surface and an outer surface spaced apart from the proximal surface; andat least one of the proximal surface or the outer surface of the visualization section having a Root Mean Square (RMS) Roughness below about 200 Angstroms.
  • 13. The endoscope of claim 12, further comprising an attachment section connected to and extending away from the visualization section, the attachment section being dimensioned to be coupled to the distal end of the endoscope.
  • 14. The endoscope of claim 13, wherein the attachment section is removably coupled to the shaft.
  • 15. The optical coupler of claim 12, wherein both the proximal surface and the outer surface of the visualization section have a Root Mean Square (RMS) Roughness below about 200 Angstroms.
  • 16. The optical coupler of claim 12, further comprising an instrument channel extending through the visualization section.
  • 17. The endoscope of claim 16, wherein the instrument channel has a proximal end for coupling to a working channel of the endoscope and a distal end at the outer surface of the visualization section.
  • 18. The endoscope of claim 12, wherein the visualization section comprises a substantially transparent material for transmitting light therethrough.
  • 19. The endoscope of claim 12, further comprising a light emitting element near, or on, the outer surface.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 17/206,119, filed Mar. 19, 2021, which is a continuation of U.S. patent application Ser. No. 16/828,134, filed Mar. 24, 2020 (now U.S. Pat. No. 10,989,912), which is a continuation of U.S. patent application Ser. No. 16/161,312, filed Oct. 16, 2018 (now U.S. Pat. No. 10,642,020), which is a continuation of U.S. patent application Ser. No. 15/653,437, filed Jul. 18, 2017 (now U.S. Pat. No. 10,101,574), which is a continuation of U.S. patent application Ser. No. 15/259,452, filed Sep. 8, 2016 (now U.S. Pat. No. 9,709,795), which is a continuation of U.S. patent application Ser. No. 14/494,090, filed Sep. 23, 2014 (now U.S. Pat. No. 9,459,442) the entire disclosures of which are incorporated herein by reference for all purposes.

US Referenced Citations (174)
Number Name Date Kind
3774614 Cook Nov 1973 A
3858577 Bass et al. Jan 1975 A
4090501 Chaitin May 1978 A
4201199 Smith May 1980 A
4207872 Meiri et al. Jun 1980 A
4340811 Yamashita et al. Jul 1982 A
4681093 Ono et al. Jul 1987 A
4696544 Costella Sep 1987 A
4744620 Ueno et al. May 1988 A
4779611 Grooters et al. Oct 1988 A
4805598 Ueda Feb 1989 A
4878725 Hessel et al. Nov 1989 A
4881810 Hasegawa Nov 1989 A
4888243 Jonas et al. Dec 1989 A
4967732 Inoue Nov 1990 A
5040715 Green et al. Aug 1991 A
5050585 Takahashi Sep 1991 A
5080660 Buelna Jan 1992 A
5104025 Main et al. Apr 1992 A
5137198 Nobis et al. Aug 1992 A
5201900 Nardella Apr 1993 A
5205459 Brinkerhoff et al. Apr 1993 A
5237984 Williams, III et al. Aug 1993 A
5271379 Phan et al. Dec 1993 A
5326013 Green et al. Jul 1994 A
5329935 Takahashi Jul 1994 A
5337734 Saab Aug 1994 A
5342388 Toller Aug 1994 A
5413052 Breezer et al. May 1995 A
5413268 Green et al. May 1995 A
5443781 Saab Aug 1995 A
5448990 De Faria-Correa Sep 1995 A
5460168 Masubuchi et al. Oct 1995 A
5471036 Sperbeck Nov 1995 A
5476206 Green et al. Dec 1995 A
5536236 Yabe et al. Jul 1996 A
5555129 Konno et al. Sep 1996 A
5562602 Yabe et al. Oct 1996 A
5569157 Nakazawa et al. Oct 1996 A
5575291 Hayakawa et al. Nov 1996 A
5605532 Schermerhorn Feb 1997 A
5632717 Yoon May 1997 A
5657921 Young et al. Aug 1997 A
5662258 Knodel et al. Sep 1997 A
5674181 Iida Oct 1997 A
5707342 Tanaka Jan 1998 A
5725474 Yasui et al. Mar 1998 A
5725475 Yasui et al. Mar 1998 A
5738629 Moll et al. Apr 1998 A
5743851 Moll et al. Apr 1998 A
5771327 Bar-Or et al. Jun 1998 A
5788628 Matsuno et al. Aug 1998 A
5808813 Lucey et al. Sep 1998 A
5840014 Miyano et al. Nov 1998 A
5860913 Yamaya et al. Jan 1999 A
5897487 Ouchi Apr 1999 A
5916148 Tsuyuki Jun 1999 A
6059719 Yamamoto et al. May 2000 A
6131789 Schulze et al. Oct 2000 A
6217509 Foley et al. Apr 2001 B1
6250532 Green et al. Jun 2001 B1
6277065 Donofrio Aug 2001 B1
6283951 Flaherty et al. Sep 2001 B1
6293907 Axon et al. Sep 2001 B1
6306081 Ishikawa et al. Oct 2001 B1
6409725 Khandkar et al. Jun 2002 B1
6416462 Tovey et al. Jul 2002 B1
6673091 Shaffer et al. Jan 2004 B1
6699180 Kobayashi Mar 2004 B2
6712524 Beatty et al. Mar 2004 B2
6723350 Burrell et al. Apr 2004 B2
6733440 Ailinger et al. May 2004 B2
6770069 Hobart et al. Aug 2004 B1
6792837 Battistone Sep 2004 B2
6855108 Ishibiki et al. Feb 2005 B2
6866627 Nozue Mar 2005 B2
6934093 Kislev et al. Aug 2005 B2
6981628 Wales Jan 2006 B2
6988650 Schwemberger et al. Jan 2006 B2
7033317 Pruitt Apr 2006 B2
7046439 Kaminsky et al. May 2006 B2
7087012 Ishibiki Aug 2006 B2
7112195 Boll et al. Sep 2006 B2
7205339 Muratoglu Apr 2007 B2
7235592 Muratoglu et al. Jun 2007 B2
7238153 Moriyama Jul 2007 B2
7245813 Brown et al. Jul 2007 B2
7464847 Viola et al. Dec 2008 B2
7537561 Yamaya et al. May 2009 B2
7553278 Kucklick Jun 2009 B2
7554743 Jiang et al. Jun 2009 B2
7566993 May Jul 2009 B2
7621868 Breidenthal et al. Nov 2009 B2
7819872 Johnson et al. Oct 2010 B2
7977255 Scheer et al. Jul 2011 B1
8180423 Mang et al. May 2012 B2
8905921 Titus Dec 2014 B2
8915931 Boudreaux et al. Dec 2014 B2
9011320 Weitzner et al. Apr 2015 B2
9459442 Miller Oct 2016 B2
9565991 Yamada Feb 2017 B2
9709795 Miller Jul 2017 B2
10101574 Miller Oct 2018 B2
10642020 Miller May 2020 B2
10989912 Miller Apr 2021 B2
11428922 Miller Aug 2022 B2
20020035311 Ouchi Mar 2002 A1
20020065515 Falwell et al. May 2002 A1
20020133148 Daniel et al. Sep 2002 A1
20030040657 Yamaya et al. Feb 2003 A1
20030181900 Long Sep 2003 A1
20040157073 Burrell et al. Aug 2004 A1
20040249246 Campos Dec 2004 A1
20040263613 Morita Dec 2004 A1
20040267092 Ishibiki Dec 2004 A1
20050043589 Pruitt Feb 2005 A1
20050080411 Ouchi Apr 2005 A1
20050131279 Boulais et al. Jun 2005 A1
20050197530 Wallace et al. Sep 2005 A1
20060030844 Knight et al. Feb 2006 A1
20060084839 Mourlas et al. Apr 2006 A1
20060173241 Ouchi et al. Aug 2006 A1
20060200176 Matsuno et al. Sep 2006 A1
20060229662 Finkielsztein et al. Oct 2006 A1
20060270900 Chin et al. Nov 2006 A1
20070038043 Gelikonov et al. Feb 2007 A1
20070066869 Hoffman Mar 2007 A1
20070066870 Ohashi et al. Mar 2007 A1
20070073108 Takahashi Mar 2007 A1
20070208219 Carter Sep 2007 A1
20070239620 Schwartz et al. Oct 2007 A1
20070260117 Zwolinski et al. Nov 2007 A1
20070282256 Hu et al. Dec 2007 A1
20070293888 Harren et al. Dec 2007 A1
20080021268 Shoroji et al. Jan 2008 A1
20080021269 Tinkham et al. Jan 2008 A1
20080033246 Matsui et al. Feb 2008 A1
20080139885 Knapp Jun 2008 A1
20080188874 Henderson Aug 2008 A1
20080262295 Kendale et al. Oct 2008 A1
20080306335 Lau et al. Dec 2008 A1
20090048483 Yamamoto Feb 2009 A1
20090048486 Surti Feb 2009 A1
20090062790 Malchano et al. Mar 2009 A1
20090098409 Yamada et al. Apr 2009 A1
20090143643 Weitzner et al. Jun 2009 A1
20090156898 Ichimura Jun 2009 A1
20090254164 Johnson et al. Oct 2009 A1
20090264154 Rofougaran Oct 2009 A1
20090315989 Adelson Dec 2009 A1
20090326328 Kucklick Dec 2009 A1
20100026940 Takegami et al. Feb 2010 A1
20100121442 Shea et al. May 2010 A1
20100203454 Brongersma et al. Aug 2010 A1
20100268027 Aono et al. Oct 2010 A1
20100286475 Robertson Nov 2010 A1
20110124960 St. Onge et al. May 2011 A1
20110152618 Surti Jun 2011 A1
20120034573 Erdmann et al. Feb 2012 A1
20120209074 Titus Aug 2012 A1
20120209090 Goodall et al. Aug 2012 A1
20120232342 Reydel Sep 2012 A1
20130040516 Pruneri et al. Feb 2013 A1
20130046138 McLawhorn Mar 2013 A1
20130090527 Axon Apr 2013 A1
20130144287 Crowley et al. Jun 2013 A1
20130190562 Smith et al. Jul 2013 A1
20130237998 Wallace et al. Sep 2013 A1
20150073214 Ueda Mar 2015 A1
20160051135 Greenberg et al. Feb 2016 A1
20160270636 Iwasaka et al. Sep 2016 A1
20170066111 Wang Mar 2017 A1
20170311789 Mulcahey et al. Nov 2017 A1
20200100655 Morishima et al. Apr 2020 A1
Foreign Referenced Citations (29)
Number Date Country
1692872 Nov 2011 CN
3532609 Mar 1987 DE
1870018 Dec 2007 EP
H0373168 Mar 1991 JP
07-178094 Jul 1995 JP
H09238893 Sep 1997 JP
05-123288 May 1999 JP
2000300570 Oct 2000 JP
3124079 Jan 2001 JP
2002233491 Aug 2002 JP
2003033319 Feb 2003 JP
2003339631 Dec 2003 JP
2005066139 Mar 2005 JP
2006026344 Feb 2006 JP
2008-029384 Feb 2008 JP
2009261830 Nov 2009 JP
5854805 Feb 2016 JP
WO 9929362 Jun 1999 WO
WO 2001085319 Nov 2001 WO
WO 2006138409 Dec 2006 WO
WO 2007029230 Mar 2007 WO
WO 2007029814 Mar 2007 WO
WO 2007147060 Dec 2007 WO
WO 2009149042 Dec 2009 WO
WO 2011085319 Jul 2011 WO
WO 2011099329 Aug 2011 WO
WO 2011148172 Dec 2011 WO
WO 2014123563 Aug 2014 WO
WO 2017011535 Jan 2017 WO
Non-Patent Literature Citations (46)
Entry
European Examination Report for EP Appl. No. 15843356.5 dated May 20, 2019, 7 pages.
Extended European Search Report for EP Appl. No. 16828548.4 dated Feb. 28, 2019.
Extended European Search Report for EP Appl. No. 16804476.6 dated Dec. 5, 2018.
Extended European Search Report and Written Opinion for EP Appl. No. 16804462-6 dated Dec. 10, 2018.
Extended European Search Report for EP Appl. No. 12747511.9 dated Jan. 3, 2018.
Extended European Search Report for EP Appl. No. 18174913.6 dated Aug. 16, 2019.
International Preliminary Report on Patentability issued in PCT/US2015/051662 dated Apr. 6, 2017.
International Search Report and Written Opinion for PCT Appl. No. PCT/US2019/012448 dated Apr. 16, 2019.
International Search Report and Written Opinion dated Oct. 26, 2016 for PCT Application No. PCT/US2016/043371, filed Jul. 21, 2016.
International Search Report issued in corresponding International Application No. PCT/US2015/051662 dated Dec. 14, 2015.
International Search Report and Written Opinion dated Sep. 21, 2012 for PCT Appl. No. PCT/US2012/025404.
Japanese Patent Office, Notification of Reasons for Refusal, JP Appl. No. 2013-554596, dated Dec. 8, 2015.
Chinese Office Action and Search Report for CN Appl. No. 201280014363, dated Mar. 23, 2015.
Chinese Office Action for CN Appl. No. 201280014363, dated Jan. 5, 2016.
Chinese Office Action for CN Appl. No. 201680045602.6 dated Jun. 5, 2019.
First Examination Report for Indian Appl. No. 6566/CHENP/2013 dated Aug. 29, 2019.
Beneq Biocompatible Coatings Webpage.
Cargille Laboratories, Inc. Material Safety Data Sheet—Cargille Optical Gel Code 0607, Jun. 3, 2005.
Depth of Field, OPMI Application Tip #2, Informed for Medical Professionals in Neuro, ENT and Spine, 2nd Issue, Oct. 2006, Published by Carl Zeiss Surgical GmbH, Germany.
Jaxton, et al., An Experimental Investigation on the Development of Hydrogels for Optical Applications, Polymer Testing, 2003, 22(4):371-374, English Abstract.
Kopp, et al., Chapter 9, Optical Principles of the Endoscope, Hysteroscopy: Visual Perspectives of Uterine Anatomy, Physiology & Pathology, 3rd Edition, Lippincott Williams & Wilkins, 2007, 19 pages.
Maquet Training Manual, Vasoview 6 Endoscopic Vessel Harvesting System, Cardiovascular, Copyright Maquet Cardiovascular LLC, Oct. 2008.
Oil Immersion, From Wikipedia, http://en.wikipedia.org/wiki/Oil.sub.--immerson, Printed Sep. 7, 2010.
Olympus Colonoscopes Outpatient Doctor Surgery Center, http://outpatientsurgicare.com/index.PHP?Facilities: Technologies:Olympus.sub.--Colonoscopes&print, Printed Oct. 26, 2010.
Olympus Disposal Distal Attachment Product Data Sheet.
Olympus Evis Exera Colonovideoscope/Sigmoidovideoscope, Olympus CF Type Q1601JUS, Today's Most Versatile Choice for Colonoscopy, Product Data Sheet.
Olympus Technologies Evis Exera II, Learn About Wide—Angle, http://www.olympusamerica.com/msg.sub.--section/ msg.sub.--endoscopy.sub.-- -technology.asp, Copyright 2010 Olympus America Inc.
Olympus Technologies Evis Exera II, Learn About Close Focus, http://www.olympusamerica.com/msg.sub.--section/ msg.sub.--endoscopy.sub.-- -technology.asp, Copyright 2010 Olympus America Inc.
Olympus NA-11J-KB Product Data Sheet.
Optical Gels for Fiber-Optic Connectors and Splices—A Tutorial, Nye Optical Products, 6 pages.
Paxton, et al., An Experimental Investigation on the Development of Hydrogels for Optical Applications, Polymer Testing, 2003, 22(4):371-374, English Abstract.
Sigma-Aldrich Poly(2-hydroxyethyl methacrylate) Product Data Sheet, http://www.sigmaaldrich.com/catalog/Product Detail, Copyright 2010 Sigma-Aldrich Co.
Sigma-Aldrich Poly(ethylene glycol) Product Data Sheet, http://www.sigmaaldrich.com/catalog/Product Detail, Copyright 2010 Sigma-Aldrich Co.
Sigma-Aldrich Poly(vinyl alcohol) Product Data Sheet, http://www.sigmaaldrich.com/catalog/Product Detail, Copyright 2010 Sigma-Aldrich Co.
Sigma-Aldrich Methacrylic acid Product Data Sheet, http://www.sigmaaldrich.com/catalog/Product Detail, Printed Sep. 3, 2010.
SmartGel Nye Nyogel OCK-451LPH Product Data Sheet, Nye Optical Products.
Smeds, et al., Photocrosslinkable Polysaccharides for in situ Hydrogel Formation, Journal of Biomedical Materials Research, 2001, 54:115-121.
Stadler, Transparent conducting oxides—An up-to-date overview, Materials 5.4:661-683, 2012.
The Basics of Silicon Chemistry, Basic Silicon Production and Siloxane Polymerization, http://www.dowcorning.com/ content/sitech/sitechbasics/siloxane.sub.--poly- merization.asp, Copyright 2000-2010 Dow Corning Corporation.
Uw Eye Research Institute, Newsletter, Point of View, Summer 2009, http://vision.wisc.edu/news.sub.--sum09.html, Printed Feb. 5, 2010.
Vinyl Sustainability Forum 2014, Title: Benefits of PVC, Date retrieved: Mar. 7, 2014 from website: http://www.pvc.org/ en/p/benefits-of-pvc, pp. 1-4.
Zeng, et al., An Endoscope Utilizing Tunable-Focus Microlenses Actuated through Infrared Light, Solid-State Sensors, Actuators and Microsystems Conference, 2009, Transducers 2009, International, Issue 21-25, pp. 1214-1217, Abstract Only.
Zeng, et al., Tunable Liquid Microlens Actuated by Infrared Light-Responsive Hydrogel, Applied Physics Letters, 2008, 93:151101-1-151101-3.
US Patent and Trademark Office; Office Action issued in U.S. Appl. No. 16/828,134, dated Oct. 30, 2020.
Chinese Office Action for Chinese Patent Application No. 201680054885.0 dated Jun. 3, 2020.
Chinese Office Action for CN Appl. No. 20168004557.9 dated Mar. 24, 2020.
Related Publications (1)
Number Date Country
20220365333 A1 Nov 2022 US
Continuations (6)
Number Date Country
Parent 17206119 Mar 2021 US
Child 17870896 US
Parent 16828134 Mar 2020 US
Child 17206119 US
Parent 16161312 Oct 2018 US
Child 16828134 US
Parent 15653437 Jul 2017 US
Child 16161312 US
Parent 15259452 Sep 2016 US
Child 15653437 US
Parent 14494090 Sep 2014 US
Child 15259452 US